Retrovir

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Hematologic Toxicity

RETROVIR® (zidovudine)
tablets, capsules, syrup, and injection have been associated with hematologic
toxicity including neutropenia and severe anemia, particularly in patients with
advanced HIV-1 disease [see WARNINGS
AND PRECAUTIONS].

Myopathy

Prolonged use of RETROVIR
has been associated with symptomatic myopathy [see WARNINGS AND PRECAUTIONS].

Lactic Acidosis and Severe
Hepatomegaly

Lactic acidosis and severe
hepatomegaly with steatosis, including fatal cases, have been reported with the
use of nucleoside analogues alone or in combination, including RETROVIR and
other antiretrovirals. Suspend treatment if clinical or laboratory findings
suggestive of lactic acidosis or pronounced hepatotoxicity occur [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

RETROVIR is the brand name for zidovudine (formerly
called azidothymidine [AZT]), a pyrimidine nucleoside analogue active against
HIV-1. The chemical name of zidovudine is 3'-azido-3'-deoxythymidine; it
has the following structural formula:

Zidovudine is a white to beige,
odorless, crystalline solid with a molecular weight of 267.24 and a solubility
of 20.1 mg per mL in water at 25°C. The molecular formula is C10H13N5O4.

RETROVIR syrup is for oral
administration. Each mL of RETROVIR syrup contains 10 mg of zidovudine and the inactive
ingredients sodium benzoate 0.2% (added as a preservative), citric acid,
flavors, glycerin, and liquid sucrose. Sodium hydroxide may be added to adjust
pH.

RETROVIR injection is a sterile
solution for IV infusion only. Each mL contains 10 mg zidovudine in water for
injection. Hydrochloric acid and/or sodium hydroxide may have been added to
adjust the pH to approximately 5.5. RETROVIR injection contains no
preservatives. The vial stoppers for RETROVIR injection contain natural rubber
latex.

What are the possible side effects of zidovudine (Retrovir)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or...

What are the precautions when taking zidovudine (Retrovir)?

Before taking zidovudine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Liquid products may contain sugar. Caution is advised if you have diabetes or any other condition that requires you to limit sugar in your diet. Ask your doctor or pharmacist about using this product safely.

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